Part 1: Zidovudine | 250mg | capsule | 40

1. International chemical name of the medicinal product: Zidovudine Strength or volume: 250mg Dosage form: capsule Package size: 40 Number of packages: 50 2. SUBJECT EVIDENCE: 2.1. Pursuant to Art. 105 and 106 of the Pzp Act, in order to confirm the compliance of the offered supplies with the requirements, characteristics or criteria specified in the description of the subject of the order or the criteria for evaluating offers or requirements related to the performance of the order, the contracting authority requests contractors to submit the following documents: 2.1.1. A valid, current at the date of submitting offers, marketing authorization in the Republic of Poland issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, or a valid, current at the date of submitting offers, marketing authorization issued by the Council of the European Union or the European Commission. 2.2. The contracting authority allows for the possibility of offering the subject of the order in foreign language packaging. The contractor must provide at least one instruction in Polish attached to the collective packaging regarding the storage and keeping of the subject of the order and a copy of the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to be released, in whole or in part, from the obligation to prepare labeling of the packaging and the leaflet attached to the packaging in Polish, or confirmation of submitting an application for such consent. In the event of obtaining consent, the contractor is obliged to provide a copy thereof to the contracting authority no later than the date of signing the contract. 2.3. The aforementioned documents must have an expiry date covering the entire period of order fulfillment. 2.4. In the event that the document's validity expires, the Contractor is obliged to provide the Contracting Authority with an additional document declaring the timely submission of an application for extension of the validity of the marketing authorization for the medicinal product, or, if obtained, a valid marketing authorization for the medicinal product, along with the documents referred to in point 2.1.1. 2.5. In accordance with Art. 107 sec. 1 of the Pzp Act, the Contractor is obliged to submit the aforementioned subject evidence along with the offer and should exercise all due diligence to ensure that these documents are complete and contain all necessary information enabling the Contracting Authority to verify their correctness. 2.6. In accordance with Art. 107 sec. 2 of the Pzp Act, the Contracting Authority provides for the possibility of supplementing the aforementioned subject evidence once within the deadline set by the Contracting Authority. 2.7. The subject evidence referred to above is submitted in the manner provided for in the regulations issued on the basis of Art. 70 of the Pzp Act. - i.e. in the Regulation of the President of the Council of Ministers of December 30, 2020, on the method of preparing and transmitting information and technical requirements for electronic documents and electronic communication tools in public procurement proceedings or competitions. 2.8. Documents prepared in a foreign language must be submitted with a Polish translation.